GxP Compliance Quality Assurance Manager

Job Locations US-MA-Bedford
Posted Date 2 months ago(5/11/2020 1:46 PM)
Job ID
2020-1322
# of Openings
1
Category
Quality

Overview

Lead product lifecycle (development through discontinuation) compliance quality assurance activities to ensure Ocular Therapeutix processes are compliant against the applicable protocols, quality agreements and/or Standard Operating Procedures. Manage cGMP, cGCP and cGLP quality activities, Quality Data Integrity Reviews (DIR), Supplier Quality Management (SQM) and internal/external auditing program.

Responsibilities

1. Lead the development, execution and maintenance of the Supplier Quality Management system to ensure uninterrupted supply of materials and services to Ocular Therapeutix including the authoring and implementation of Quality Agreements, executing Supplier and material approval steps within QAD and maintaining a current Approved Supplier List (ASL). Support in the training of Lead Auditors.
2. Lead the establishment, performance and maintenance of a risk-based program for the continual and appropriate oversight of all GxP suppliers.
3. Lead the development, execution and maintenance of the Supplier Corrective Action Responses program (SCARs).
4. Lead the internal and external audit program. Conduct Quality assessments / audits of Suppliers, Principle Investigators and Ocular Therapeutix GLP, GCP and GMP activities, follow-up on agreed upon corrective actions and train or approve lead auditors as needed.
5. Support and/or perform Data Integrity Reviews of non-clinical/clinical studies, clinical/commercial product manufacturing and regulatory submissions as needed.
6. Develop, monitor and report on GxP Compliance QA metrics including Supplier Corrective Actions and internal and external auditing status to drive compliance quality management.
7. Support with Inspection Execution and Readiness as required.
8. Oversee non-clinical/clinical quality system activities including non-conformances, corrective actions, protocol approval, clinical temperature excursions and return material authorizations (RMA).
9. Manage Product Complaint and Recall Programs
10. Perform other duties as assigned

Qualifications

  • Bachelor’s degree in Life Sciences
  • At least 8 years’ experience in the pharmaceutical or biopharmaceutical industry with a minimum of 5 years of Quality Assurance and Supplier Quality Management experience
  • Excellent knowledge of US cGMPs, cGLPs and cGCPs
  • Strong auditing experience to both GMP and GCP requirements
  • Certified Quality Auditor (ASQ or equivalent) required
  • Strong interpersonal, negotiation and communication skills
  • > 20% travel may be required

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